CN112088297A - Method for determining adhesion of hemostatic tissue sealant patch - Google Patents
Method for determining adhesion of hemostatic tissue sealant patch Download PDFInfo
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- CN112088297A CN112088297A CN201980031065.3A CN201980031065A CN112088297A CN 112088297 A CN112088297 A CN 112088297A CN 201980031065 A CN201980031065 A CN 201980031065A CN 112088297 A CN112088297 A CN 112088297A
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- 238000000034 method Methods 0.000 title claims abstract description 63
- 230000002439 hemostatic effect Effects 0.000 title claims abstract description 59
- 239000000565 sealant Substances 0.000 title claims description 61
- 239000000853 adhesive Substances 0.000 claims abstract description 28
- 230000001070 adhesive effect Effects 0.000 claims abstract description 28
- 238000007789 sealing Methods 0.000 claims abstract description 25
- 229940030225 antihemorrhagics Drugs 0.000 claims abstract description 22
- 239000002874 hemostatic agent Substances 0.000 claims abstract description 19
- 239000012530 fluid Substances 0.000 claims abstract description 9
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 claims description 10
- 239000002953 phosphate buffered saline Substances 0.000 claims description 10
- 239000000243 solution Substances 0.000 claims description 6
- 230000003213 activating effect Effects 0.000 claims description 4
- 238000004026 adhesive bonding Methods 0.000 claims description 2
- 239000000463 material Substances 0.000 description 10
- 238000005259 measurement Methods 0.000 description 9
- 108010049003 Fibrinogen Proteins 0.000 description 5
- 102000008946 Fibrinogen Human genes 0.000 description 5
- 229940012952 fibrinogen Drugs 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 239000000203 mixture Substances 0.000 description 5
- 108090000190 Thrombin Proteins 0.000 description 3
- 238000003908 quality control method Methods 0.000 description 3
- 229960004072 thrombin Drugs 0.000 description 3
- 102000009123 Fibrin Human genes 0.000 description 2
- 108010073385 Fibrin Proteins 0.000 description 2
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 2
- 230000004913 activation Effects 0.000 description 2
- 229920000249 biocompatible polymer Polymers 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 229950003499 fibrin Drugs 0.000 description 2
- 230000000025 haemostatic effect Effects 0.000 description 2
- 239000004310 lactic acid Substances 0.000 description 2
- 230000000704 physical effect Effects 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 238000004154 testing of material Methods 0.000 description 2
- 229920000298 Cellophane Polymers 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 230000008094 contradictory effect Effects 0.000 description 1
- 229940081104 fibrinogen / thrombin Drugs 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 235000013372 meat Nutrition 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000002985 plastic film Substances 0.000 description 1
- -1 polyethylene Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 238000004445 quantitative analysis Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N19/00—Investigating materials by mechanical methods
- G01N19/04—Measuring adhesive force between materials, e.g. of sealing tape, of coating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
- A61F13/0256—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the parametric properties of the adhesive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/84—Accessories, not otherwise provided for, for absorbent pads
- A61F2013/8488—Accessories, not otherwise provided for, for absorbent pads including testing apparatus
- A61F2013/8491—Accessories, not otherwise provided for, for absorbent pads including testing apparatus including test methods
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pathology (AREA)
- Immunology (AREA)
- General Physics & Mathematics (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Dermatology (AREA)
- Materials Engineering (AREA)
- Epidemiology (AREA)
- Materials For Medical Uses (AREA)
- Surgical Instruments (AREA)
Abstract
A method for measuring the adhesive strength of a hemostatic tissue patch. Two patches are attached to the facing surfaces leaving the side normally sealing the tissue exposed. A fluid is placed on one of the patches to activate the hemostatic agent, the patches are held together long enough to adhere to each other, and then pulled apart. The force required to separate them was measured to determine the adhesive strength of the patch. In contrast to the literature methods, the methods of the present invention provide excellent reproducibility.
Description
Reference to related documents
This application claims priority from U.S. provisional patent application No. 62/646,409 filed on 3, 22/2018.
Technical Field
The present invention relates generally to the measurement of physical properties of tissue sealant patches containing hemostatic compositions. And more particularly to a method for measuring the adhesive strength of such patches.
Background
Tissue sealant films and patches comprising a hemostatic agent (e.g., fibrin or a combination of fibrinogen and thrombin) and a backing made of a material such as a biocompatible polymer are well known in the art. For example, in U.S. patent nos. 5631011, 6054122, 6056970, 6162241, 6699844 and 7189410; PCT (International) patent application publication Nos. WO96/40174, WO99/21908, WO2006/044882, WO2008/019128, and WO 2014/174509; U.S. patent application publication nos. 2006/0155235, 2007/0162121, 2011/0071498, 2011/0288462, and 2012/0070485; and examples of such films and patches are disclosed in european patent application publication No. 2556842. All of these references are incorporated herein by reference in their entirety.
For patch design and quality control, it is important to be able to accurately and reproducibly measure the physical properties (particularly adhesive strength) of a tissue sealant patch.
U.S. patent No. 6056970 discloses a method for measuring the mechanical strength of a patch material, in which a patch is placed in a tensile strength tester and the maximum load at which the material breaks is determined.
U.S. patent application publication No. 2007/0162121 discloses that the adhesive strength of a sealant composition used to attach the edge of a protective sleeve to tissue can be determined by bonding two plastic sheets with an adhesive formulation and determining the strength of the bond. The method provides no details and does not disclose a method for measuring the adhesive strength of a patch comprising a haemostatic material.
U.S. patent application publication No. 2012/0070485 discloses the use of the ASTM D412-98a method to measure the tensile strength of a patch material.
European patent application publication No. 2556842 discloses a qualitative method for determining the adhesion of a tissue sealant compound or a film containing a sealant compound by placing the sealant on a slide, adding water, placing a coverslip over the sealant, and empirically verifying adhesion by observing the adherence of the coverslip to the slide.
Thus, it can be seen that an accurate and repeatable quantitative method for determining the adhesive strength of a hemostatic tissue sealant patch remains a long-felt unmet need.
Disclosure of Invention
The invention disclosed herein is directed to meeting this long felt need. Surprisingly, the inventors have found that measuring the force required to separate two identical hemostatic tissue sealant patches connected by a hemostatic sealant provides a more reliable and reproducible method for measuring the adhesive strength of the patches than heretofore known in the art.
It is therefore an object of the present invention to disclose a method of determining the adhesive strength of a haemostatic tissue sealant patch comprising at least one tissue sealing surface and a haemostat, wherein the method comprises:
attaching a first hemostatic tissue sealant patch to a first surface such that the tissue sealing surface of the first hemostatic tissue sealant patch remains exposed;
attaching a second hemostatic tissue sealant patch to a second surface such that the tissue sealing surface of the second hemostatic tissue sealant patch remains exposed;
activating the hemostatic agent on at least one of the hemostatic tissue sealant patches;
pressing the tissue sealing surfaces of the hemostatic sealant patches together at a first predetermined time, thereby adhering the hemostatic sealant patches to each other.
After the first predetermined time, applying a force to the hemostatic patch in an opposite direction to the force applied in the step of pressing the tissue sealing surfaces together; and the combination of (a) and (b),
measuring the force required to completely separate the hemostatic sealant patches from each other, thereby determining the adhesive strength of the hemostatic tissue patches.
It is another object of the present invention to disclose such a method, wherein said first and second hemostatic tissue sealant patches are circular and characterized by an area of 2cm2。
It is another object of the current invention to disclose the method as defined in any of the above, wherein said step of attaching said hemostatic tissue sealant patches to said surface comprises attaching each of said patches such that a force of at least 50N is required to detach said patch from said surface.
It is another object of the current invention to disclose the method as defined in any of the above, wherein said step of attaching said hemostatic tissue sealant patch to said surface comprises attaching said hemostatic tissue sealant patch by a method selected from the group consisting of gluing and double-sided taping.
It is another object of the current invention to disclose the method as defined in any of the above, wherein the step of activating the hemostatic agent comprises applying a predetermined volume of fluid onto the exposed surface of the first hemostatic tissue sealant patch. In some preferred embodiments of the invention, the step of applying a predetermined volume of fluid comprises applying a Phosphate Buffered Saline (PBS) solution to the first hemostatic sealant patch. In some preferred embodiments of the invention, the step of applying a predetermined volume of fluid comprises applying 125 μ l of a 1% PBS solution to the first hemostatic sealant patch.
It is another object of the current invention to disclose the method as defined in any of the above, wherein the step of pressing the tissue sealing surfaces of the hemostatic sealant patch together at a first predetermined time comprises pressing the tissue sealing surfaces together with a force of about 5N. In some preferred embodiments of the invention, the step of pressing the tissue sealing surfaces of the hemostatic sealant patch together at a first predetermined time comprises pressing the tissue sealing surfaces together with a force of about 5N for 3 minutes. In some preferred embodiments of the invention, the step of pressing the tissue sealing surfaces of the hemostatic sealant patch together at a first predetermined time includes pressing the tissue sealing surfaces together with a force for a period of time sufficient to adhere the patch to tissue.
It is another object of the current invention to disclose the method as defined in any of the above, wherein after the step of pressing the tissue sealing surfaces of the hemostatic sealant patch together for a first predetermined time, pressing on the surfaces is stopped for a second predetermined time. In some preferred embodiments of the invention, the second predetermined time is about 10 seconds.
Drawings
The invention will now be described with reference to the accompanying drawings, in which:
fig. 1 illustrates a step of attaching a patch to an opposing surface according to one embodiment of the methods disclosed herein;
FIG. 2 illustrates the step of adding a fluid to one patch to activate a hemostatic agent according to one embodiment of the methods disclosed herein;
fig. 3 illustrates a method at a point after the step of pressing two patches together until they adhere to each other, and the direction of movement of the two surfaces when they are pulled apart, according to one embodiment of the methods disclosed herein;
fig. 4 shows two patches at the moment of onset of separation according to one embodiment of the methods disclosed herein;
FIG. 5 shows two patches after being separated from each other, demonstrating that the method provides a measure of the adhesive strength of the side of the patches that will be exposed to tissue, according to one embodiment of the method disclosed herein; and the combination of (a) and (b),
fig. 6 shows a graph of typical measurements of hemostatic tissue patch adhesive strength according to one embodiment of the methods disclosed herein.
Detailed Description
In the following description, various aspects of the present invention will be described. For purposes of explanation, specific details are set forth in order to provide a thorough understanding of the present invention. It will be apparent to those skilled in the art that other embodiments of the invention may be practiced without departing from the spirit or essential characteristics thereof. Accordingly, all embodiments described herein should be considered in all respects only as illustrative and not restrictive. Additionally, in some cases, the different method steps are described separately for clarity or brevity. All non-contradictory combinations of steps of the inventive methods disclosed herein are contemplated by the inventors to be within the scope of the invention even if specific combinations are not explicitly described.
As used herein, the term "hemostatic sealant patch" is used to describe a device or composition for stopping, slowing, or preventing leakage of fluid into or out of a body part, which includes an occlusive material and a hemostatic agent. Non-limiting examples of occlusive materials include biocompatible polymers formed into sheets or films; woven and non-woven materials, and the like. Non-limiting examples of hemostatic agents include fibrin and a fibrinogen/thrombin mixture. Thus, a "hemostatic sealant patch" as defined herein may include devices that are optionally known in the literature under the terms "bandage", "dressing", "film", and the like, including the two components listed.
As used herein, the abbreviation "PBS" stands for "phosphate buffered saline".
In the following description, the term "about" when applied to numerical values refers to a range of ± 25% of the nominal value.
Surprisingly, the inventors have found that measuring the adhesive force of a hemostatic patch to another similar patch gives more reliable and repeatable results than methods currently known in the art, in which the adhesive force of the patch is measured as the force required to separate the patch from a tissue substitute (e.g., meat) or from a substance (e.g., glass). Thus, in the method of the invention, two patches are attached to each other by activation of the haemostatic agent, and the force required to separate them is then measured.
Reference is now made to fig. 1-5, which are screenshots captured from a movie of an exemplary embodiment of the method of the present invention, showing the various steps in a preferred embodiment of the method.
Referring now to fig. 1, the setup of the measurement is shown. Two hemostatic tissue sealant patches 100a and 100b are attached to two facing surfaces (101 a and 101b, respectively), with the side that will be in contact with the tissue exposed in actual use. The hemostatic tissue sealant patch shown in fig. 1 is of the type disclosed in PCT patent WO2014/174509 (hereinafter' 509) which comprises thrombin/fibrinogen/CaCl incorporated into one surface of a membrane made of a polyethylene glycol-polycaprolactone-lactic acid triblock copolymer2A hemostatic agent. For patches in which the hemostatic agent is applied or incorporated on only one surface, that surface is the surface exposed for both 100a and 100 b. Attachment to a surface can be accomplished by any method that results in the patch adhering more firmly to the surface (than to the patch itself). In a preferred embodiment, the patch is attached to a surface such that the adhesive force is at least 50N. As one example, the patch may be attached to the surface by using a double-sided tape (e.g., cellophane tape or duct tape), or the patch may be adhered to the surface. In some embodiments, the two surfaces are facing surfaces of a piston that is incorporated into or as an integral part of a commercially available material testing machine. Such machines are particularly useful because they provide accurate and repeatable results, and can generally be programmed to perform the methods disclosed herein. Although the embodiment shown in the figures shows two patches oriented on an axis perpendicular to the table on which the device is located, the method may use the patches in any absolute orientation as long as the active surfaces are facing each other.
After both patches have been attached to the facing surfaces, the hemostatic agent is activated. Referring now to FIG. 2, this step of one embodiment of the method is shown. In this embodiment, an aliquot of liquid 120 is applied to the exposed surface of one of the patches. One non-limiting example of a liquid suitable for use in the methods of the present invention is PBS. Sufficient liquid must be added to activate the hemostatic agent. For example, for the patch shown in the figure (the patch disclosed in' 509, its area is 2cm2)，1x PBA 125 μ l aliquot of the S solution is sufficient to activate the hemostatic agent. In the embodiment of the method shown in fig. 2, the liquid is introduced by pipette onto the surface of the patch, but any suitable method for placing the liquid on the patch may be used.
After the hemostatic agent has been activated, the two patches are pressed together. Referring now to fig. 3, this step of the method is shown. Pressing the two patches together, i.e. moving towards each other along an axis perpendicular to the facing surfaces until their surfaces are in contact; the direction of movement is indicated by the arrow in fig. 3. They are then held together long enough to allow the patches to adhere to each other. In the case of the patches shown in the figures, it was found that pressing the patches together with a force of 5N for three minutes was sufficient to adhere the patches to each other; these conditions simulate the forces and times typically used to attach tissue sealants in vivo. In some embodiments of the invention, the force on the patch is relaxed (i.e., no force is applied to the patch in any direction) for a predetermined period of time. This time is generally less than the time to press the patches together, typically about 10 seconds.
The two patches were then pulled apart. Referring now to fig. 4, this step of the method is shown. As indicated by the arrows in the figure, a force is applied perpendicular to the facing surfaces in the opposite direction to that used in the previous step. In the case of measurements on a commercially available material testing machine, the two pistons are preferably separated by setting the machine to move the two pistons at a constant speed. The figure shows the point where two patches just started to separate. The maximum force measured during this procedure was recorded as the adhesive force of the patch.
Referring now to fig. 5, the system is shown after the measurement is complete. As can be seen from the figure, the two patches remain intact, indicating that the adhesion between the two patches after activation of the hemostatic agent is measured, and not some other parameter (e.g., adhesion of the other side of the patch to the piston, tensile strength of the polymer backing, or adhesion of the hemostatic material to the polymer backing).
Because the method disclosed herein provides a repeatable and accurate measurement of the adhesive strength of the hemostatic tissue patch, it may also be used as part of a quality control procedure. Because of its good accuracy and precision, the method can be used to determine whether a suspect batch meets predetermined criteria. Standard adhesivity is set based on measurements on a number of patches known to be made according to the appropriate protocol, and then one or more samples from a suspect lot are tested. If the suspected patch's adhesiveness is within the standard measurement range, the suspected lot may be considered acceptable within the standard, whereas if the suspected patch's adhesiveness is significantly different from the established standard, the suspected patch may be considered not to have been made to the standard.
Examples of the invention
The following examples are provided to assist those of ordinary skill in the art in making and using the inventions disclosed herein and are not to be construed as limiting in any way.
Example 1
Testing of adhesive Strength of a hemostatic Patch of the type disclosed in' 509 that included a hemostatic agent comprising thrombin, fibrinogen and CaCl incorporated into the surface of a polymeric backing made of a polyethylene-caprolactone-lactic acid triblock copolymer2. Two areas of 2cm were covered with double-sided tape2Each of the circular patches of (a) was attached to the piston of a 10ml syringe to which a double-sided duct tape had been attached, leaving the surface incorporating the hemostatic agent exposed. The piston was fixed to the fixture of a Testometric M250 material tester. A 125 μ l aliquot of 1% PBS solution was then placed on the underlying patch, and the two patches were pressed together with a force of 5N for 3 minutes. The force was then relaxed to 0N for 10 seconds, after which the clamp was held at a constant 50mm s-1Is divided. The adhesive strength of the patch was determined as the maximum force required for separation. Table 1 gives the results of a series of repeated runs. The uncertainty of the mean is one standard deviation.
TABLE 1
Example 2
The following examples demonstrate the methods disclosed herein and how they can be used for quality control. A batch of patches manufactured nominally in the same manner as described in the previous example were suspected of being prepared with the wrong amount of fibrinogen sealant. As a test, the adhesive strength of several suspect patches prepared according to the methods disclosed herein was compared to the adhesive strength of known patches prepared according to the correct protocol and to the adhesive strength of patches over-doped with 50% fibrinogen sealant. The results (adhesive strength in N) are summarized in table 2.
TABLE 2
As can be seen from the results summarized in the table, the adhesive strength of the patches in the suspect batches was similar to that of the patches with 50% additional sealant added, whereas those prepared according to the conventional protocol had adhesive strengths that were the same within experimental error as those of the patches used in the previous examples.
Reference is now made to fig. 6, which shows a graph of the measurement results set forth in table 2.
Claims (12)
1. A method for determining the adhesive strength of a hemostatic tissue sealant patch comprising at least one tissue sealing surface and a hemostatic agent, the method comprising:
attaching a first hemostatic tissue sealant patch to a first surface such that the tissue sealing surface of the first hemostatic tissue sealant patch remains exposed;
attaching a second hemostatic tissue sealant patch to a second surface such that the tissue sealing surface of the second hemostatic tissue sealant patch remains exposed;
activating the hemostatic agent on at least one of the hemostatic tissue sealant patches;
pressing the tissue sealing surfaces of the hemostatic sealant patches together for a first predetermined time, thereby adhering the hemostatic sealant patches to each other;
after the first predetermined time, applying a force to the hemostatic patch in a direction opposite to the force applied in the step of pressing the tissue sealing surfaces together; and the combination of (a) and (b),
measuring the force required to completely separate the hemostatic sealant patches from each other, thereby determining the adhesive strength of the hemostatic tissue patches.
2. The method of claim 1, wherein the first and second hemostatic tissue sealant patches are circular and 2cm in area2。
3. The method of claim 1, wherein said step of attaching said hemostatic tissue sealant patches to said surface comprises attaching each of said patches such that a force of at least 50N is required to detach said patch from said surface.
4. The method of claim 1, wherein the step of attaching the hemostatic tissue sealant patch to the surface comprises attaching the hemostatic tissue sealant patch by a method selected from the group consisting of gluing and double-sided taping.
5. The method of claim 1, wherein the step of activating the hemostatic agent includes applying a predetermined volume of fluid to the exposed surface of the first hemostatic tissue sealant patch.
6. The method of claim 5, wherein the step of applying a predetermined volume of fluid includes applying a Phosphate Buffered Saline (PBS) solution to the exposed surface of the first hemostatic sealant patch.
7. The method of claim 6, wherein the step of applying a predetermined volume of fluid comprises applying 125 μ l of a 1x PBS solution to the first hemostatic sealant patch.
8. The method of claim 1, wherein the step of pressing the tissue sealing surfaces of the hemostatic sealant patch together for a first predetermined time comprises pressing the tissue sealing surfaces together with a force of about 5N.
9. The method of claim 8, wherein the step of pressing the tissue sealing surfaces of the hemostatic sealant patch together for a first predetermined time comprises pressing the tissue sealing surfaces together with a force of about 5N for about 3 minutes.
10. The method of claim 1, wherein the step of pressing the tissue sealing surfaces of the hemostatic sealant patch together for a first predetermined time comprises pressing the tissue sealing surfaces together with a force for a period of time sufficient to adhere the patch to tissue.
11. The method of claim 1, wherein after the step of pressing the tissue sealing surfaces of the hemostatic sealant patch together for a first predetermined time, stopping pressing on the surfaces for a second predetermined time.
12. The method of claim 11, wherein the second predetermined time is about 10 seconds.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862646409P | 2018-03-22 | 2018-03-22 | |
| US62/646,409 | 2018-03-22 | ||
| PCT/IL2019/050308 WO2019180713A1 (en) | 2018-03-22 | 2019-03-19 | Method for determining the adhesive force of a hemostatic tissue sealant patch |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN112088297A true CN112088297A (en) | 2020-12-15 |
| CN112088297B CN112088297B (en) | 2023-05-26 |
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| CN201980031065.3A Active CN112088297B (en) | 2018-03-22 | 2019-03-19 | Method for determining adhesion of hemostatic tissue sealant patch |
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| Country | Link |
|---|---|
| US (1) | US11662299B2 (en) |
| EP (1) | EP3769068B1 (en) |
| JP (1) | JP7227341B2 (en) |
| KR (1) | KR20210018788A (en) |
| CN (1) | CN112088297B (en) |
| AU (1) | AU2019240359B2 (en) |
| CA (1) | CA3094759A1 (en) |
| ES (1) | ES2941283T3 (en) |
| GB (1) | GB2586544B (en) |
| IL (1) | IL277453B2 (en) |
| WO (1) | WO2019180713A1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US11471556B2 (en) | 2015-10-19 | 2022-10-18 | Sealantium Medical Ltd. | Fibrinogen-based tissue adhesive patch |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6054122A (en) | 1990-11-27 | 2000-04-25 | The American National Red Cross | Supplemented and unsupplemented tissue sealants, methods of their production and use |
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| WO2019180713A1 (en) | 2019-09-26 |
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| AU2019240359B2 (en) | 2023-02-02 |
| EP3769068A1 (en) | 2021-01-27 |
| GB202015395D0 (en) | 2020-11-11 |
| IL277453B2 (en) | 2023-06-01 |
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